Get 40% Off
🚨 Volatile Markets? Find Hidden Gems for Serious OutperformanceFind Stocks Now

BRIEF-Neovasc To Explore HDE Approval Pathway And Alternate Trial Designs For The Reducer Following Guidance From The FDA

Published 2019-07-12, 09:32 a/m
Updated 2019-07-12, 09:40 a/m
BRIEF-Neovasc To Explore HDE Approval Pathway And Alternate Trial Designs For The Reducer Following Guidance From The FDA

July 12 (Reuters) - Neovasc Inc NVCN.TO :

* NEOVASC TO EXPLORE HDE APPROVAL PATHWAY AND ALTERNATE TRIAL DESIGNS FOR THE REDUCER FOLLOWING GUIDANCE FROM THE FDA

* NEOVASC - FDA HAS RECOMMENDED CO TO CONSIDER ALTERNATE APPROACHES SUCH AS: HUMANITARIAN DEVICE EXEMPTION PATHWAY OR ALTERNATE CLINICAL TRIAL DESIGNS

* NEOVASC INC - COMPANY HAS DECIDED TO EXPLORE A TWO-PRONGED APPROACH

* NEOVASC INC - WILL EXPLORE AN ALTERNATE IDE STUDY DESIGN, IN CONJUNCTION WITH OUR SUPPORTIVE U.S. CARDIOLOGISTS

* NEOVASC INC- WILL WORK WITH FDA TO PURSUE OPTION FOR REDUCER TO BE CLASSIFIED AS HUMANITARIAN USE DEVICE SEEKING AN HDE APPROVAL PATHWAY

* NEOVASC - WILL EVALUATE AN ALTERNATE INVESTIGATIONAL DEVICE EXEMPTION ("IDE") CLINICAL TRIAL DESIGN FOR CLASS III AND IV PATIENTS

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.